Sodium Stearyl Fumarate

SIAL/PHR1444 - Pharmaceutical Secondary Standard; Certified Reference Material

Synonym: Sodium stearyl fumarate; (E)-2-Butenedioic acid monooctadecyl ester sodium salt; Sodium octadecyl fumarate

CAS Number: 4070-80-8
Empirical Formula (Hill Notation): C₂₂H₃₉NaO₄
Molecular Weight: 390.53
Linear Formula: C₂₂H₃₉NaO₄
Product Type: Chemical

agency	traceable to Ph. Eur. S0808000
	traceable to USP 1614705
API family	sodium stearyl fumarate
application(s)	pharmaceutical (small molecule)
CofA	current certificate can be downloaded
format	neat
grade	certified reference material
	pharmaceutical secondary standard
InChI	1S/C22H40O4.Na/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-20-26-22(25)19-18-21(23)24;/h18-19H,2-17,20H2,1H3,(H,23,24);/q;+1/p-1/b19-18+;
InChI key	STFSJTPVIIDAQX-LTRPLHCISA-M
packaging	pkg of 1 g
Quality Level	300
storage temp.	2-30°C
technique(s)	gas chromatography (GC): suitable
	HPLC: suitable

Analysis Note:	These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.
Application:	These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Footnote:	To see an example of a Certificate of Analysis for this material enter LRAC3332 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.
General description:	Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards. Sodium Stearyl Fumarate is a water soluble lubricant, which is widely used in the pharmaceutical industry for the compression of tablets. Its ability to reduce friction, adhesion to the punches, tablet strength and the disintegration time was investigated.
Other Notes:	This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Hazard Codes	Xi
Risk Statements	36/38
Safety Statements	26
RIDADR	NONH for all modes of transport
WGK Germany	WGK 3
Flash Point(F)	Not applicable
Flash Point(C)	Not applicable

Storage Temp.	2-30°C
UNSPSC	41116107